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Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics

AIMS: To illustrate the use of pharmacokinetic–pharmacodynamic (PK–PD) models to select rational starting doses in clinical trials within the minimum anticipated biological effect level (MABEL) principle using literature data and through simulations. METHODS: The new European Medicines Agency guidan...

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書目詳細資料
主要作者: Agoram, Balaji M
格式: Artigo
語言:Inglês
出版: Blackwell Science Inc 2009
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在線閱讀:https://ncbi.nlm.nih.gov/pmc/articles/PMC2670372/
https://ncbi.nlm.nih.gov/pubmed/19076987
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2008.03297.x
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